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Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01210404
First Posted: September 28, 2010
Last Update Posted: June 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.

Condition Intervention Phase
Chronic Hepatitis C Drug: filibuvir Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Methadone plasma pharmacokinetic parameters, AUC24, Cmax [ Time Frame: day 1 ]
  • Methadone plasma pharmacokinetic parameters, AUC24, Cmax [ Time Frame: day 11 ]

Secondary Outcome Measures:
  • Methadone plasma pharmacokinetic parameters Tmax and C24h [ Time Frame: day 1 ]
  • Methadone plasma pharmacokinetic parameters Tmax and C24h [ Time Frame: day 11 ]
  • Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. [ Time Frame: day 2 ]
  • Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. [ Time Frame: day 11 ]
  • Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments. [ Time Frame: days 0-12 ]
  • Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement . [ Time Frame: days 0-12 ]

Enrollment: 12
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.0 Drug: filibuvir
Filibuvir, 600mg bid administered along with methadone on days 2-11

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.

Exclusion Criteria:

  • Evidence of chronic diseases including HIV, HBV or HCV.
  • Evidence of acute or chronic liver disease.
  • Treatment with prescription or nonprescription drugs other than methadone within 7 days.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210404


Locations
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01210404     History of Changes
Other Study ID Numbers: A8121023
First Submitted: September 27, 2010
First Posted: September 28, 2010
Last Update Posted: June 7, 2011
Last Verified: June 2011

Keywords provided by Pfizer:
Drug interaction with methadone.

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents